The NHS and DNA patents

The Human Genetics Commission (HGC) recently published a report on Intellectual Property and DNA Diagnostics which has triggered newspaper reports with the headlines that NHS hospitals face DNA patent law suits (see for example The Telegraph).

The report revolves around the patenting of DNA sequences and DNA marker tests and the subsequent use of these patents by public sector health workers in diagnostic tests. Currently NHS laboratories often use patented DNA marker tests for diagnostics without a licence and this constitutes an infringement of intellectual property (IP) rights, although currently enforcement action is rare due to the cost and the relatively rare diseases for which the NHS uses such tests. What the HGC report and the newspaper fail to make clear is that this kind of use will only be an infringement if the patent is registered in the UK and unlicensed use is made in the UK. Companies with DNA sequence patents in the US seem more willing to litigate matters, but they will only be able to enforce their US patents in the US.

Companies in the UK are currently cautious about taking action against hospitals to enforce their patents due to the potential public backlash and the high cost of litigation. However DNA biomarker tests are increasingly being developed for more common diseases, such as breast and cervical cancer, and it is likely that companies will then be more proactive about enforcing their rights as the value of their product will be higher. This will create a greater tension between the industry’s desire to exploit the fruits of their investment and the routine infringement by NHS laboratories.

This is not a debate about whether the patenting itself is inherently wrong or ethical, but what public sector workers and the NHS should do once there is a registered IP right which is enforceable in this country; laboratories will need to consider carefully whether they require a licence to carry out diagnostic tests for patients.

Given the structure of the NHS and DH, it may be difficult to keep an overview of what licences have been granted and which are required to carry out diagnostic testing or research. The HGC has made a number of recommendations in its report urging policymakers in the public sector and the industry to address the issue. The HGC recommended, for example, that the DH establishes an IP monitoring function for DNA markers and that licensing guidelines are developed for public sector workers. At a national level, the HGC recommended that support should be given to senior management in the NHS to develop capacity to manage IP issues in this area as it is currently unclear who is responsible within the NHS for the practical implementation of policy in this area.

It remains to be seen what developments follow from the HGC recommendations, although it is advisable for NHS bodies to start reviewing whether licences are required for any DNA marker testing they are carrying out.